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Trial registered on ANZCTR


Registration number
ACTRN12613001078741
Ethics application status
Not yet submitted
Date submitted
25/09/2013
Date registered
26/09/2013
Date last updated
26/09/2013
Type of registration
Prospectively registered

Titles & IDs
Public title
A Postpartum Motivational Interviewing Group Intervention for Women with a History of Gestational Diabetes
Scientific title
A pilot study to evaluate the effect of a postpartum motivational interviewing group intervention on motivation, exercise and eating habits in women with a history of gestational diabetes
Secondary ID [1] 283305 0
Nil
Universal Trial Number (UTN)
UTN: U1111-1148-3995
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Gestational Diabetes Mellitus 290189 0
Condition category
Condition code
Metabolic and Endocrine 290577 290577 0 0
Diabetes
Reproductive Health and Childbirth 290581 290581 0 0
Childbirth and postnatal care

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
A motivational interviewing group which involves reflection on the experience of gestational diabetes, what the women know about life after gestational diabetes, a discussion on their current lifestyle and encouraging intrinsic motivation to make changes if appropriate. This one off session will take 2 hours and can be followed up with additional support at home or via telephone if deemed useful.
Intervention code [1] 288025 0
Lifestyle
Intervention code [2] 288026 0
Behaviour
Comparator / control treatment
Usual care (no treatment)
Control group
Active

Outcomes
Primary outcome [1] 290596 0
Motivation- measured using readiness rulers for importance, confidence and readiness to change: fat intake, sugar intake, portion size, exercise, fruit and vegetable intake, keeping a healthy weight.
Timepoint [1] 290596 0
Baseline, end of group session and 1 month follow-up
Secondary outcome [1] 304862 0
Eating habits (rapid eating assessment for participants shortened version)
Timepoint [1] 304862 0
Baseline and 1 month follow-up
Secondary outcome [2] 304876 0
Physical exercise (International physical activity questionnaire)
Timepoint [2] 304876 0
Baseline and follow-up (1 month)

Eligibility
Key inclusion criteria
women with a history of gestational diabetes in their last pregnancy, 3-12 months postpartum; 18 years or over; able to give informed consent; fluent in English
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
Yes
Key exclusion criteria
major psychiatric disorders; severe cognitive dysfunction.

Study design
Purpose of the study
Prevention
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
A local PHO will recruit participants through their database. They will make telephone contact with them and ask if they would like to be part of a study. Interested individuals will have their details passed onto the researcher who will then make contact with them and provide additional information. Participants will be allocated a participant number on recruitment, and then randomized to the control group or intervention group through an internet number randomizer. Allocation will be consealed as the person recruiting participants will not know which group they will be part of until the complete number of participants have been recruited.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Internet number generator
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint/s
Efficacy
Statistical methods / analysis
The sample size selected in this study is 20 participants. This is based on recommendations of not having more than 5-7 participants per group session if it is facilitated by one facilitator. We have decided to over recruit slightly in case some participants are unable to attend the group session on the day. Given this study is a pilot study we did not recruit based on power calculations. We realise that this will impact on the statistical tests that we run. We plan to use one way repeated measures ANOVA or Friedman's ANOVA.

Recruitment
Recruitment status
Not yet recruiting
Date of first participant enrolment
Anticipated
4/11/2013
Actual
Date of last participant enrolment
Anticipated
2/12/2013
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
20
Accrual to date
Final
Recruitment outside Australia
Country [1] 5444 0
New Zealand
State/province [1] 5444 0

Funding & Sponsors
Funding source category [1] 288037 0
Charities/Societies/Foundations
Name [1] 288037 0
Diabetes Projects Trust
Country [1] 288037 0
New Zealand
Primary sponsor type
Charities/Societies/Foundations
Name
Diabetes Projects Trust
Address
100 Alexander Crescent
Otara
Auckland 2159
NZ
Country
New Zealand
Secondary sponsor category [1] 286760 0
None
Name [1] 286760 0
Address [1] 286760 0
Country [1] 286760 0

Ethics approval
Ethics application status
Not yet submitted
Ethics committee name [1] 289960 0
Northern Regional X Ethics Committee
Ethics committee address [1] 289960 0
Ethics committee country [1] 289960 0
New Zealand
Date submitted for ethics approval [1] 289960 0
26/09/2013
Approval date [1] 289960 0
Ethics approval number [1] 289960 0

Summary
Brief summary
Research has shown that women with a history of gestational diabetes are at a much higher risk of getting gestational diabetes in future pregnancies and type 2 diabetes in the future than those who have not had gestational diabetes. Furthermore, these risks can be ameliorated by maintaining a healthy lifestyle i.e. regular exercise and healthy eating. Modifying lifestyle factors is often a challenging task and can take considerable time, commitment and motivation. It is therefore not surprising that patients often experience a sense of ambivalence around whether they want to make changes or not, regardless of the health benefits.

Health practitioners have generally encouraged patients to make lifestyle changes through persuasive advice giving. However, the research shows that while this is an effective means of eliciting behaviour change for some patients, it does not appear to be effective for the majority of patients. Patient centred approaches to lifestyle modification (in which the patient does most of the talking and the patient and health practitioner work collaboratively) have produced more promising results. Furthermore, motivational interviewing (a patient centred approach) has shown significant effects on a range of physiological measures (including BMI) and a range of health problems e.g. diabetes and weight-related problems.

In this pilot study a between groups experimental design will be used as part of a PDSA cycle to explore the efficacy of a 2-hour motivational interviewing group for women with a history of gestational diabetes. Process data will be collected in addition to outcome data on perceived risk of diabetes, motivation for change, physical activity levels, and eating habits
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 43282 0
Miss Heidi Baxter
Address 43282 0
Diabetes Projects Trust
100 Alexander Crescent
Otara
Auckland 2159
Country 43282 0
New Zealand
Phone 43282 0
649 273 9650
Fax 43282 0
Email 43282 0
[email protected]
Contact person for public queries
Name 43283 0
Heidi Baxter
Address 43283 0
Diabetes Projects Trust
100 Alexander Crescent
Otara
Auckland 2159
Country 43283 0
New Zealand
Phone 43283 0
649 273 9650
Fax 43283 0
Email 43283 0
[email protected]
Contact person for scientific queries
Name 43284 0
Heidi Baxter
Address 43284 0
Diabetes Projects Trust
100 Alexander Crescent
Otara
Auckland 2159
Country 43284 0
New Zealand
Phone 43284 0
649 273 9650
Fax 43284 0
Email 43284 0
[email protected]

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
No documents have been uploaded by study researchers.

Documents added automatically
No additional documents have been identified.